HEPCLUDEX Powder for solution for injection (2021)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

HEPCLUDEX 2 mg powder for solution for injection.

2. Qualitative and quantitative composition

Each vial contains bulevirtide acetate equivalent to 2 mg bulevirtide. For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Powder for solution for injection (powder for injection). The powder is white to off-white. After reconstitution, solution with a pH of approximately 9.0 and osmolality of approximately 300 mOsm/kg.

4.1. Therapeutic indications

Hepcludex is indicated for the treatment of chronic hepatitis delta virus (HDV) infection in plasma (or serum) HDV-RNA positive adult patients with compensated liver disease.

4.2. Posology and method of administration

Treatment should be initiated only by a physician experienced in the treatment of patients with HDV infection. Posology Bulevirtide should be administered at 2 mg once daily (every 24 h ± 4 h) by subcutaneous ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4. Special warnings and precautions for use

HDV and HBV genotype HDV genotype 1 was predominant in the clinical trials population. It is not known whether HDV or HBV genotype affects the clinical efficacy of bulevirtide. Decompensated liver disease ...

4.5. Interaction with other medicinal products and other forms of interaction

In vitro, it has been shown, that certain medicinal products can inhibit bulevirtide target sodiumtaurocholate co-transporting polypeptide (NTCP). The co-administration of such medicinal products ...

4.6. Fertility, pregnancy and lactation

Pregnancy There are no or limited amount of data from the use of bulevirtide in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. ...

4.7. Effects on ability to drive and use machines

The product has minor influence on the ability to drive and use machines. Patients should be informed that dizziness has been reported during treatment with bulevirtide (see section 4.8).

4.8. Undesirable effects

Summary of the safety profile The most frequently reported adverse reactions were asymptomatic, dose dependent and reversible (after discontinuation of treatment) increase in bile salts (very common) and ...

4.9. Overdose

There are no data on human overdose with bulevirtide. If overdose occurs, the patient must be monitored for evidence of toxicity and given standard supportive treatment as necessary.

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: antivirals for systemic use, other antivirals ATC code: J05AX28 Mechanism of action Bulevirtide blocks the entry of HBV and HDV into hepatocytes by binding to and ...

5.2. Pharmacokinetic properties

The pharmacokinetic properties of bulevirtide were characterised after intravenous and subcutaneous administration. The exposure of bulevirtide increased disproportionally while the clearance and volume ...

5.3. Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single and repeated dose toxicity, and toxicity to reproduction and development. No genotoxicity ...

6.1. List of excipients

Sodium carbonate anhydrous Sodium hydrogen carbonate Mannitol Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment)

6.2. Incompatibilities

This medicinal product must not be mixed with other medicinal products, except those mentioned in section 6.6.

6.3. Shelf life

24 months. After reconstitution, chemical and physical in-use stability has been demonstrated for 2 hours at room temperature (up to 25°C). From a microbiological point of view, it is recommended that ...

6.4. Special precautions for storage

Store in a refrigerator (2°C-8°C). In order to protect from light, keep the vials in the outer carton.

6.5. Nature and contents of container

Colourless glass vial with bromobutyl rubber stopper, sealed with a flip off cap (aluminium with plastic disc). Pack-size of 30 vials.

6.6. Special precautions for disposal and other handling

Each vial is intended for single use only and the excess of unused product must be properly disposed of. Water for injections, syringes, needle tips and alcohol wipes should be provided to the patient. ...

7. Marketing authorization holder

Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland

8. Marketing authorization number(s)

EU/1/20/1446/001

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 31 July 2020 Date of latest renewal: 02 August 2021

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